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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04884230
Other study ID # UnidadInternacional
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 5, 2017
Est. completion date May 5, 2020

Study information

Verified date May 2021
Source Unidad Internacional de Cirugia Bariatrica y Metabolica
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

Background: Roux-en-Y gastric bypass (RYGB) is a surgery with low rate complications. However, it is not exempt from them, and 1-6% suffer complications such as postoperative bleeding. Many intraoperative techniques have been evaluated to reduce postoperative bleeding, like the oversewing or reinforcement of the staple line. This study aims to evaluate the rate of postoperative bleeding in the oversewing of the staple line of the gastric remnant group versus the stapling only group. Methods: This is a 2-center, case-control study. The investigators randomly selected two groups who underwent RYGB or OAGB: group A (n=225) with oversewing from 2019-2020 and group B (n=225) with stapling only between the period of 2017-2018; both groups with similar demographic characteristics.


Description:

This case-control study was conducted in the International Unit of Bariatric and Metabolic Surgery of "Clinica La Sagrada Familia" located in Maracaibo, Venezuela, and in "Grupo Medico Santa Paula" Caracas, Venezuela. All procedures were performed by a single experienced bariatric surgeon during the period 2017-2020. The Ethics committees of Clinica "La Sagrada Familia" and "Grupo Medico Santa Paula" approved this study. The investigators selected 225 patients (group A) from the period 2019-2020 where the stapling line of the gastric remnant was oversewn and another group of 225 patients (group B) from the period of 2017-2018 with stapling alone.


Recruitment information / eligibility

Status Completed
Enrollment 250
Est. completion date May 5, 2020
Est. primary completion date February 5, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - Our inclusion criteria were patients older than 18 years, body mass index (BMI) > 30kg/m2 with or without comorbidities that underwent RYGB or one anastomosis gastric bypass (OAGB). Exclusion Criteria: - We exclude from our study any patient with psychiatric disorder, open surgery history, history of previous bariatric surgery, non-controlled comorbidity at the moment of surgery, and patients under the age of 18

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Oversewing
Oversewing of the gastric remnant

Locations

Country Name City State
Venezuela CCSF MAracaibo Zulia

Sponsors (1)

Lead Sponsor Collaborator
Unidad Internacional de Cirugia Bariatrica y Metabolica

Country where clinical trial is conducted

Venezuela, 

Outcome

Type Measure Description Time frame Safety issue
Primary Reduce bleeding assessing melena Through study completion, 6 month average
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